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Observational StudyBiliary Atresia Research Network Northeast

Sponsor:

Yale University

Code:

NCT06184971

Conditions

Biliary Atresia

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization.

Conditions

Biliary Atresia

Study ID

NCT06184971

Start date

May 6, 2024

Status verified date

Jun, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

Children with a healthcare encounter related to biliary atresia at a participating institution during the study period (January 1st, 2012 through December 31st, 2021)
Age 12 years and younger at the time of the qualifying encounter during the study period (encompassing patients born between January 2nd, 1999 through December 31st, 2021)
Diagnosis of biliary atresia, based on one of the following ICD-10 codes:

Q44.2 Atresia of bile ducts
Q44.3 Congenital stenosis and stricture of bile ducts
Q44.4 Disorders of the biliary tract with major complication or comorbidity
Q44.5 Other congenital malformations of the bile ducts
Q44.6 Disorders of the biliary tract without major complication or comorbidity

Exclusion Criteria:

Patients aged 13 years old or older during the study period (i.e. those born before January 2nd, 1999)
Patients born and/or diagnosed with biliary atresia after the end of the study period (i.e. those born after December 31st, 2021)
No diagnosis of biliary atresia
History of biliary atresia without any episodes of care related to biliary atresia during the study period (e.g. a teenager with history of BA who underwent Kasai procedure as an infant and has no current issues related to their BA and is receiving care for an unrelated reason)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Death [ Time Frame: 10 years ]
Kasai procedure [ Time Frame: 10 years ]
Liver transplant [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Isabelle Curran

203-785-2701 isabelle.curran@yale.edu

Beverly Newlove

beverly.newlove@yale.edu

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Richard Weiss

rweiss@connecticutchildrens.org

Principal Investigator:

Richard Weiss

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Isabelle Curran

isabelle.curran@yale.edu

Eastern Maine Medical Center

Recruiting

Bangor, Maine, United States, 04401

Contacts

Todd Heaton

theaton@northernlight.org

Principal Investigator:

Todd Heaton

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Isabelle Curran

isabelle.curran@yale.edu

Principal Investigator:

Christopher Turner

Massachusetts General Hospital for Children

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alyssa Stetson

alyssaE_Stetson@DFCI.HARVARD.EDU

Principal Investigator:

Danielle Cameron

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Claire Ostertag-Hill

claire.osterag-hill@childrens.harvard.edu

Principal Investigator:

Alex Cuenca

Baystate

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Nicole Corriveau

nicole.corriveau@baystatehealth.org

Principal Investigator:

Michael Tirabassi

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Zachary Ballinger

zachary.ballinger@umassmemorial.org

Principal Investigator:

Muriel Cleary

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Daniel Croitoru

daniel.p.croitoru@hitchcock.org

Principal Investigator:

Daniel Croitoru

Albany Medical Center/Bernard & Millie Duke's Children's Hospital

Recruiting

Albany, New York, United States, 12208

Contacts

Rebecca Brocks

brocks@amc.edu

Principal Investigator:

Rebecca Brocks

John R. Oishei Children's Hospital

Recruiting

Buffalo, New York, United States, 14203

Contacts

Ben Ham

Pham1@kaleidahealth.org

Principal Investigator:

Ben Ham

University of Rochester Medical Center/Golisano Children's Hospital

Recruiting

Rochester, New York, United States, 14642

Contacts

David Darcy

David_Darcy@URMC.Rochester.edu

Principal Investigator:

David Darcy

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Mohamed Salahie

salahiem@upstate.edu

Principal Investigator:

Tamer Ahmed

Rhode Island Hospital/Hasbro Children's Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Debra Watson-Smith

debra.watson-smith@brownphysicians.org

Principal Investigator:

Julie Monteagudo

More Information

Sponsor

Yale University

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by Yale University on 2025-07-01.